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64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

ConditionProstatic Neoplasms, Castration-Resistant
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorClarity Pharmaceuticals Ltd

About this trial

The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent;

≥18 years of age;

Eastern Cooperative Oncology Group performance status of 0 to 2;

Life expectancy >6 months;

Disqualifiers

Major surgery within 12 weeks prior to enrollment into the study;

Brain metastasis;

Histologic diagnosis of small cell or neuroendocrine prostate cancer;

Prior history of leukemia or Myelodysplastic Syndrome;

Trial design

Design model

Single group

Treatments tested in this trial

  • 64Cu-SAR-bisPSMA

    Drug

    64Cu-SAR-bisPSMA

  • 67Cu-SAR-bisPSMA

    Drug

    67Cu-SAR-bisPSMA

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: 67Cu-SAR-bisPSMAExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Biodistribution of 64Cu-SAR-bisPSMA

Biodistribution will be calculated by utilizing the PET/CT scans.

Time frame
48 hours
2

Dosimetry of 64Cu-SAR-bisPSMA

Dosimetry will be calculated by utilizing the PET/CT scans.

Time frame
48 hours
3

Modelling of 67Cu-SAR-bisPSMA dosimetry utilizing the 64Cu-SAR-bisPSMA PET/CT scans

Dosimetry will be calculated by utilizing the PET/CT scans.

Time frame
48 hours
4

Maximum Tolerated Dose (MTD) or Maximum Feasible Dose of a single dose of 67Cu-SAR-bisPSMA

MDT as determined by cohort observations of dose limiting toxicities (DLT)

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clarity Pharmaceuticals Ltd

Lead sponsor

Source ClinicalTrials.gov
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